MAUDE Adverse Event Report: TORNIER SAS AEQUALIS REVERSED GLENOIS SPHERE; N/A

Catalog Number DWD180

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Code Available (3191)

Event Date 05/02/2015

Event Type  Injury  

Event Description

After two weeks from the initial surgery, baseplate with sphere and screws dropped off from glenoid.Revision surgery done on (b)(6) 2015.

Manufacturer Narrative

This is the initial report submitted regarding this surgical event and medical advice.

• Brand Name: AEQUALIS REVERSED GLENOIS SPHERE
• Type of Device: N/A
• Manufacturer (Section D): TORNIER SAS; montbonnot ; FR
• Manufacturer Contact: segolene pollet ; 161 rue lavoisier; monbonnot saint martin 38330 ; 76613500
• MDR Report Key: 4810620
• MDR Text Key: 18384936
• Report Number: 9610667-2015-00107
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K081059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: DWD180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/02/2015
• Initial Date FDA Received: 05/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other